Surgical instrument with rapid post event detection

ABSTRACT

A surgical instrument is disclosed, the instrument including: a handle assembly; a jaw assembly including a staple cartridge containing a plurality of staples and an anvil to form the plurality of staples upon firing; a lockout mechanism configured to prevent reuse of the jaw assembly; a drive assembly at least partially located within the handle and connected to the jaw assembly; a motor operatively coupled to the drive assembly; and a controller operatively coupled to the motor, the controller configured to control supply of electrical current to the motor and to monitor a current draw of the motor, wherein the controller is further configured to terminate the supply of electrical current to the motor in response to a drop in the current draw.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical apparatuses, devices and/orsystems for performing endoscopic surgical procedures and methods of usethereof. More specifically, the present disclosure relates toelectromechanical, hand-held surgical apparatus, devices and/or systemsconfigured for use with removable disposable end effectors and/or singleuse end effectors for clamping, cutting and/or stapling tissue.

2. Background of the Related Art

A number of surgical device manufacturers have developed product lineswith proprietary drive systems for operating and/or manipulatingelectromechanical surgical devices. In many instances theelectromechanical surgical devices include a reusable handle assembly,and disposable or single use end effectors. The end effectors areselectively connected to the handle assembly prior to use and thendisconnected from the handle assembly following use in order to bedisposed of or in some instances sterilized for re-use.

Many of these electromechanical surgical devices include complex drivecomponents that utilize a variety of user interfaces that accept userinputs (e.g., controls) for controlling the devices as well as providefeedback to the user. To prevent inadvertent activation, various lockoutmechanisms exist. However, existing mechanisms only provide a singlesafety check.

Unlike purely mechanical systems, powered systems possess the ability todetect and react to some failures even after they have occurred. If thisdetection is completed in a rapid manner, corrective actions andemergency measures can be implemented to reduce and/or prevent patientand/or user harm. Accordingly, there is a need for systems andapparatuses having redundant safety mechanisms that can detect suchfailures.

SUMMARY

The present disclosure provides a surgical instrument including: ahandle assembly; a jaw assembly including a staple cartridge containinga plurality of staples and an anvil to form the plurality of staplesupon firing; a lockout mechanism configured to prevent reuse of the jawassembly; a drive assembly at least partially located within the handleand connected to the jaw assembly and the lockout mechanism; a motor ormotors operatively coupled to the drive assembly; and a controlleroperatively coupled to the motor, the controller configured to controlsupply of electrical current to the motor and to monitor a current drawof the motor, wherein the controller is further configured to terminatethe supply of electrical current to the motor in response to a drop inthe current draw, or detection of other triggering metrics (RPM,acceleration, etc.).

According to one aspect of the present disclosure, the jaw assembly adrive beam coupled to the lockout mechanism, the lockout mechanismconfigured to transition between an unlocked state and a locked stateupon distal movement of the drive beam.

According to one aspect of the present disclosure, the drop in thecurrent draw corresponds to a failure of the lockout mechanism toproperly prohibit device use after the lockout mechanism should havebeen triggered. According to one aspect of the present disclosure, thelockout mechanism includes a locking member pivotal between an unlockedposition and a locked position.

According to one aspect of the present disclosure, the jaw assemblyfurther includes a housing defining a projection mounted thereinconfigured to engage the locking member upon retraction of the drivebeam.

The present disclosure also provides for a surgical instrument,including: a handle assembly; a disposable end effector removablycoupled to the handle assembly, the disposable end effector including ajaw assembly including a staple cartridge containing a plurality ofstaples and an anvil to form the plurality of staples upon firing; and adrive assembly at least partially located within the handle andconnected to the jaw assembly, the drive assembly including a lockoutmechanism. The surgical instrument also includes a motor(s) operativelycoupled to the drive assembly; a drive circuit coupled to the motor(s)and configured to measure a current draw of the motor (+ other metrics);and a controller operatively coupled to the motor, the controllerconfigured to terminate the supply of electrical current to the motor inresponse to a drop in the current draw indicative of a failure of thelockout mechanism.

According to one aspect of the present disclosure, the controller isfurther configured to store a fault state in a memory in response to thedrop in the current draw.

According to one aspect of the present disclosure, the fault state iscleared after the disposable end effector is removed from the handleassembly.

According to one aspect of the present disclosure, the controller isconfigured to detect the drop in the current draw based on a rate ofchange of the current draw.

According to one aspect of the present disclosure, the jaw assemblyincludes a drive beam coupled to the lockout mechanism.

According to one aspect of the present disclosure, the lockout mechanismconfigured to transition between an unlocked state and a locked stateupon distal movement of the drive beam.

According to one aspect of the present disclosure, the drop in thecurrent draw corresponds to a failure of the lockout mechanism totransition into the locked state upon retraction of the drive beam.

According to one aspect of the present disclosure, the lockout mechanismincludes a locking member pivotal between an unlocked position and alocked position.

According to one aspect of the present disclosure, the jaw assemblyfurther includes a housing defining a projection mounted thereinconfigured to engage the locking member upon retraction of the drivebeam.

According to one aspect of the present disclosure, the surgicalinstrument further includes a control assembly coupled to thecontroller, wherein the controller disregards user inputs in response tothe drop in the current draw.

A method for controlling a surgical instrument is also provided by thepresent disclosure. The method including the steps of: activating amotor operatively coupled to disposable end effector. The end effectorincluding: a drive beam coupled to a jaw assembly including a staplecartridge containing a plurality of staples and an anvil to form theplurality of staples upon firing; and a lockout mechanism coupled to thedrive beam and configured to transition from an unlocked state to alocked state upon retraction of the drive beam. The method furtherincluding: measuring a current draw of the motor; and terminating supplyof electric current to the motor in response to a drop off of thecurrent draw indicative of a failure of the lockout mechanism.

According to one aspect of the present disclosure, the method furtherincludes the step of storing a fault state in a memory in response tothe drop in the current draw.

According to one aspect of the present disclosure, the method furtherincludes the step of clearing the fault state after the disposable endeffector is removed from the handle assembly.

DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure are described herein withreference to the accompanying drawings, wherein:

FIG. 1 is a perspective, disassembled view of an electromechanicalsurgical system including a surgical instrument, an adapter, and an endeffector, according to the present disclosure;

FIG. 2 is a perspective view of the surgical instrument of FIG. 1,according to the present disclosure;

FIG. 3 is perspective, exploded view of the surgical instrument of FIG.1, according to the present disclosure;

FIG. 4 is a perspective view of a battery of the surgical instrument ofFIG. 1, according to the present disclosure;

FIG. 5 is a top, partially-disassembled view of the surgical instrumentof FIG. 1, according to the present disclosure;

FIG. 6 is a front, perspective view of the surgical instrument of FIG. 1with the adapter separated therefrom, according to the presentdisclosure;

FIG. 7 is a side, cross-sectional view of the surgical instrument ofFIG. 1, as taken through 7-7 of FIG. 2, according to the presentdisclosure;

FIG. 8 is a top, cross-sectional view of the surgical instrument of FIG.1, as taken through 8-8 of FIG. 2, according to the present disclosure;

FIG. 9 is a perspective, exploded view of a end effector of FIG. 1,according to the present disclosure;

FIG. 10A is a top view of a locking member according to the presentdisclosure;

FIG. 10B is a perspective view of the locking member of FIG. 10Aaccording to the present disclosure;

FIG. 11 is a schematic diagram of the surgical instrument of FIG. 1according to the present disclosure;

FIG. 12 is a flow chart of a method for controlling the surgical staplerof FIG. 1 according to the present disclosure;

FIGS. 13-15 are plots of mechanical resistance, rotational speed, andcurrent applied to a motor of the surgical stapler as controlled by themethod of the present disclosure; and

FIG. 16 is a plot of current draw of the motor of the surgical stapleras controlled by the method of the present disclosure.

DETAILED DESCRIPTION

A surgical system, in accordance with an embodiment of the presentdisclosure, is generally designated as 10, and is in the form of apowered hand held electromechanical instrument configured for selectiveattachment thereto of a plurality of different end effectors that areeach configured for actuation and manipulation by the powered hand heldelectromechanical surgical instrument.

As illustrated in FIG. 1, surgical instrument 100 is configured forselective connection with an adapter 200, and, in turn, adapter 200 isconfigured for selective connection with an end effector or single useloading unit or reload 300.

As illustrated in FIGS. 1-3, surgical instrument 100 includes a handlehousing 102 having a lower housing portion 104, an intermediate housingportion 106 extending from and/or supported on lower housing portion104, and an upper housing portion 108 extending from and/or supported onintermediate housing portion 106. Intermediate housing portion 106 andupper housing portion 108 are separated into a distal half-section 110 athat is integrally formed with and extending from the lower portion 104,and a proximal half-section 110 b connectable to distal half-section 110a by a plurality of fasteners. When joined, distal and proximalhalf-sections 110 a, 110 b define a handle housing 102 having a cavity102 a therein in which a circuit board 150 and a drive mechanism 160 issituated.

Distal and proximal half-sections 110 a, 110 b are divided along a planethat traverses a longitudinal axis “X” of upper housing portion 108, asseen in FIGS. 2 and 3. Handle housing 102 includes a gasket 112extending completely around a rim of distal half-section and/or proximalhalf-section 110 a, 110 b and being interposed between distalhalf-section 110 a and proximal half-section 110 b. Gasket 112 seals theperimeter of distal half-section 110 a and proximal half-section 110 b.Gasket 112 functions to establish an air-tight seal between distalhalf-section 110 a and proximal half-section 110 b such that circuitboard 150 and drive mechanism 160 are protected from sterilizationand/or cleaning procedures.

In this manner, the cavity 102 a of handle housing 102 is sealed alongthe perimeter of distal half-section 110 a and proximal half-section 110b yet is configured to enable easier, more efficient assembly of circuitboard 150 and a drive mechanism 160 in handle housing 102.

Intermediate housing portion 106 of handle housing 102 provides ahousing in which circuit board 150 is situated. Circuit board 150 isconfigured to control the various operations of surgical instrument 100,as will be set forth in additional detail below.

Lower housing portion 104 of surgical instrument 100 defines an aperture(not shown) formed in an upper surface thereof and which is locatedbeneath or within intermediate housing portion 106. The aperture oflower housing portion 104 provides a passage through which wires 152pass to electrically interconnect electrical components (a battery 156,as illustrated in FIG. 4, a circuit board 154, as illustrated in FIG. 3,etc.) situated in lower housing portion 104 with electrical components(circuit board 150, drive mechanism 160, etc.) situated in intermediatehousing portion 106 and/or upper housing portion 108.

Handle housing 102 includes a gasket 103 disposed within the aperture oflower housing portion 104 (not shown) thereby plugging or sealing theaperture of lower housing portion 104 while allowing wires 152 to passtherethrough. Gasket 103 functions to establish an air-tight sealbetween lower housing portion 106 and intermediate housing portion 108such that circuit board 150 and drive mechanism 160 are protected fromsterilization and/or cleaning procedures.

As shown, lower housing portion 104 of handle housing 102 provides ahousing in which a rechargeable battery 156, is removably situated.Battery 156 is configured to supply power to any of the electricalcomponents of surgical instrument 100. Lower housing portion 104 definesa cavity (not shown) into which battery 156 is inserted. Lower housingportion 104 includes a door 105 pivotally connected thereto for closingcavity of lower housing portion 104 and retaining battery 156 therein.

With reference to FIGS. 3 and 5, distal half-section 110 a of upperhousing portion 108 defines a nose or connecting portion 108 a. A nosecone 114 is supported on nose portion 108 a of upper housing portion108. Nose cone 114 is fabricated from a transparent material. Anillumination member 116 is disposed within nose cone 114 such thatillumination member 116 is visible therethrough. Illumination member 116is may be a light emitting diode printed circuit board (LED PCB).Illumination member 116 is configured to illuminate multiple colors witha specific color pattern being associated with a unique discrete event.

Upper housing portion 108 of handle housing 102 provides a housing inwhich drive mechanism 160 is situated. As illustrated in FIG. 5, drivemechanism 160 is configured to drive shafts and/or gear components inorder to perform the various operations of surgical instrument 100. Inparticular, drive mechanism 160 is configured to drive shafts and/orgear components in order to selectively move tool assembly 304 of endeffector 300 (see FIGS. 1 and 9) relative to proximal body portion 302of end effector 300, to rotate end effector 300 about a longitudinalaxis “X” (see FIG. 2) relative to handle housing 102, to move anvilassembly 306 relative to cartridge assembly 308 of end effector 300,and/or to fire a stapling and cutting cartridge within cartridgeassembly 308 of end effector 300.

The drive mechanism 160 includes a selector gearbox assembly 162 that islocated immediately proximal relative to adapter 200. Proximal to theselector gearbox assembly 162 is a function selection module 163 havinga first motor 164 that functions to selectively move gear elementswithin the selector gearbox assembly 162 into engagement with an inputdrive component 165 having a second motor 166.

As illustrated in FIGS. 1-4, and as mentioned above, distal half-section110 a of upper housing portion 108 defines a connecting portion 108 aconfigured to accept a corresponding drive coupling assembly 210 ofadapter 200.

As illustrated in FIGS. 6-8, connecting portion 108 a of surgicalinstrument 100 has a cylindrical recess 108 b that receives a drivecoupling assembly 210 of adapter 200 when adapter 200 is mated tosurgical instrument 100. Connecting portion 108 a houses three rotatabledrive connectors 118, 120, 122.

When adapter 200 is mated to surgical instrument 100, each of rotatabledrive connectors 118, 120, 122 of surgical instrument 100 couples with acorresponding rotatable connector sleeve 218, 220, 222 of adapter 200 asshown in FIG. 6. In this regard, the interface between correspondingfirst drive connector 118 and first connector sleeve 218, the interfacebetween corresponding second drive connector 120 and second connectorsleeve 220, and the interface between corresponding third driveconnector 122 and third connector sleeve 222 are keyed such thatrotation of each of drive connectors 118, 120, 122 of surgicalinstrument 100 causes a corresponding rotation of the correspondingconnector sleeve 218, 220, 222 of adapter 200.

The mating of drive connectors 118, 120, 122 of surgical instrument 100with connector sleeves 218, 220, 222 of adapter 200 allows rotationalforces to be independently transmitted via each of the three respectiveconnector interfaces. The drive connectors 118, 120, 122 of surgicalinstrument 100 are configured to be independently rotated by drivemechanism 160. In this regard, the function selection module 163 ofdrive mechanism 160 selects which drive connector or connectors 118,120, 122 of surgical instrument 100 is to be driven by the input drivecomponent 165 of drive mechanism 160.

Since each of drive connectors 118, 120, 122 of surgical instrument 100has a keyed and/or substantially non-rotatable interface with respectiveconnector sleeves 218, 220, 222 of adapter 200, when adapter 200 iscoupled to surgical instrument 100, rotational force(s) are selectivelytransferred from drive mechanism 160 of surgical instrument 100 toadapter 200.

The selective rotation of drive connector(s) 118, 120 and/or 122 ofsurgical instrument 100 allows surgical instrument 100 to selectivelyactuate different functions of end effector 300. As will be discussed ingreater detail below, selective and independent rotation of first driveconnector 118 of surgical instrument 100 corresponds to the selectiveand independent opening and closing of tool assembly 304 of end effector300, and driving of a stapling/cutting component of tool assembly 304 ofend effector 300. Also, the selective and independent rotation of seconddrive connector 120 of surgical instrument 100 corresponds to theselective and independent articulation of tool assembly 304 of endeffector 300 transverse to longitudinal axis “X” (see FIG. 2).Additionally, the selective and independent rotation of third driveconnector 122 of surgical instrument 100 corresponds to the selectiveand independent rotation of end effector 300 about longitudinal axis “X”(see FIG. 2) relative to handle housing 102 of surgical instrument 100.

As mentioned above and as illustrated in FIGS. 5 and 8, drive mechanism160 includes a selector gearbox assembly 162; and a function selectionmodule 163, located proximal to the selector gearbox assembly 162, thatfunctions to selectively move gear elements within the selector gearboxassembly 162 into engagement with second motor 166. Thus, drivemechanism 160 selectively drives one of drive connectors 118, 120, 122of surgical instrument 100 at a given time.

As illustrated in FIGS. 1-3, handle housing 102 supports a controlassembly 107 on a distal surface or side of intermediate housing portion108. The control assembly 107 is a fully-functional mechanicalsubassembly that can be assembled and tested separately from the rest ofthe instrument 100 prior to coupling thereto.

Control assembly 107, in cooperation with intermediate housing portion108, supports a pair of finger-actuated control buttons 124, 126 and apair rocker devices 128, 130 within a housing 107 a. The control buttons124, 126 are coupled to extension shafts 125, 127 respectively. Inparticular, control assembly 107 defines an upper aperture 124 a forslidably receiving the extension shaft 125, and a lower aperture 126 afor slidably receiving the extension shaft 127.

The control assembly 107 and its components (e.g., control buttons 124,126 and rocker devices 128, 130) my be formed from low friction,self-lubricating, lubricious plastics or materials or coatings coveringthe moving components to reduce actuation forces, key component wear,elimination of galling, smooth consistent actuation, improved componentand assembly reliability and reduced clearances for a tighter fit andfeel consistency. This includes the use of plastic materials in thebushings, rocker journals, plunger bushings, spring pockets, retainingrings and slider components as described in further detail below.Molding the components in plastic also provides net-shape or mesh-shapedcomponents with all of these performance attributes. Plastic componentseliminate corrosion and bi-metal anodic reactions under electrolyticconditions such as autoclaving, steam sterilizations and cleaning. Pressfits with lubricious plastics and materials also eliminate clearanceswith minimal strain or functional penalties on the components whencompared to similar metal components.

Suitable materials for forming the components of the control assembly107 include, but are not limited to, polyamines, polyphenylene sulfides,polyphthalamides, polyphenylsulfones, polyether ketones,polytetrafluoroethylenes, and combinations thereof. These components maybe used in the presence or absence of lubricants and may also includeadditives for reduced wear and frictional forces.

Reference may be made to a commonly-owned U.S. patent application Ser.No. 13/331,047, the entire contents of which are incorporated byreference herein, for a detailed discussion of the construction andoperation of the surgical instrument 100.

Referring to FIG. 9, drive assembly 360 of end effector 300 includes aflexible drive beam 364 having a distal end which is secured to adynamic clamping member 365, and a proximal engagement section 368.Engagement section 368 includes a stepped portion defining a shoulder370. A proximal end of engagement section 368 includes diametricallyopposed inwardly extending fingers 372. Fingers 372 engage a hollowdrive member 374 to fixedly secure drive member 374 to the proximal endof beam 364. Drive member 374 defines a proximal porthole 376 a whichreceives a connection member of drive tube 246 (FIG. 1) of adapter 200when end effector 300 is attached to distal coupling 230 of adapter 200.

When drive assembly 360 is advanced distally within tool assembly 304,an upper beam 365 a of clamping member 365 moves within a channeldefined between anvil plate 312 and anvil cover 310 and a lower beam 365b moves over the exterior surface of carrier 316 to close tool assembly304 and fire staples therefrom.

Proximal body portion 302 of end effector 300 includes a sheath or outertube 301 enclosing an upper housing portion 301 a and a lower housingportion 301 b. The housing portions 301 a and 301 b enclose anarticulation link 366 having a hooked proximal end 366 a which extendsfrom a proximal end of end effector 300. Hooked proximal end 366 a ofarticulation link 366 engages a coupling hook (not shown) of adapter 200when end effector 300 is secured to distal housing 232 of adapter 200.When drive bar 258 of adapter 200 is advanced or retracted as describedabove, articulation link 366 of end effector 300 is advanced orretracted within end effector 300 to pivot tool assembly 304 in relationto a distal end of proximal body portion 302.

As illustrated in FIG. 9 above, cartridge assembly 308 of tool assembly304 includes a staple cartridge 305 supportable in carrier 316. Thecartridge can be permanently installed in the end effector 300 or can bearranged so as to be removable and replaceable. Staple cartridge 305defines a central longitudinal slot 305 a, and three linear rows ofstaple retention slots 305 b positioned on each side of longitudinalslot 305 a. Each of staple retention slots 305 b receives a singlestaple 307 and a portion of a staple pusher 309. During operation ofinstrument 100, drive assembly 360 abuts an actuation sled and pushesactuation sled through cartridge 305. As the actuation sled movesthrough cartridge 305, cam wedges of the actuation sled sequentiallyengage staple pushers 309 to move staple pushers 309 vertically withinstaple retention slots 305 b and sequentially eject staples 307therefrom for formation against anvil plate 312.

The hollow drive member 374 includes a lockout mechanism 373 thatprevents a firing of previously fired end effectors 300. The lockoutmechanism 373 includes a locking member 371 pivotally coupled within adistal porthole 376 b via a pin 377, such that locking member 371 ispivotal about pin 377 relative to drive member 374.

With reference to FIGS. 10A and 10B, locking member 371 defines achannel 379 formed between elongate glides 381 and 383. Web 385 joins aportion of the upper surfaces of glides 381 and 383. Web 385 isconfigured and dimensioned to fit within the porthole 376 b of the drivemember 374. Horizontal ledges 389 and 391 extend from glides 381 and 383respectively. As best shown in FIG. 9, a spring 393 is disposed withinthe drive member 374 and engages horizontal ledge 389 and/or horizontalledge 391 to bias locking member 371 downward.

In operation, the locking member 371 is initially disposed in itspre-fired position at the proximal end of the housing portions 301 a and301 b with horizontal ledge 389 and 391 resting on top of projections303 a, 303 b formed in the sidewalls of housing portion 301 b. In thisposition, locking member 371 is held up and out of alignment with aprojection 303 c formed in the bottom surface of housing portion 301 b,distal of the projection 303 a, 303 b, and web 385 is in longitudinaljuxtaposition with shoulder 370 defined in drive beam 364. Thisconfiguration permits the anvil 306 to be opened and repositioned ontothe tissue to be stapled until the surgeon is satisfied with theposition without activating locking member 371 to disable the disposableend effector 300.

Upon distal movement of the drive beam 364 by the drive tube 246,locking member 371 rides off of projections 303 a, 303 b and is biasedinto engagement with housing portion 301 b by the spring 393, distal ofprojection 303 c. Locking member 371 remains in this configurationthroughout firing of the apparatus.

Upon retraction of the drive beam 364, after at least a partial firing,locking member 371 passes under projections 303 a, 303 b and rides overprojection 303 c of housing portion 301 b until the distal-most portionof locking member 371 is proximal to projection 303 c. The spring 393biases locking member 371 into juxtaposed alignment with projection 303c, effectively disabling the disposable end effector. If an attempt ismade to reactuate the apparatus, loaded with the existing end effector300, the locking member 371 will abut projection 303 c of housingportion 301 b and will inhibit distal movement of the drive beam 364.

The end effector 300 may also include one or more mechanical lockoutmechanisms, such as those described in commonly-owned U.S. Pat. Nos.5,071,052, 5,397,046, 5,413,267, 5,415,335, 5,715,988, 5,718,359,6,109,500, the entire contents of all of which are incorporated byreference herein.

Another embodiment of the instrument 100 is shown in FIG. 11. Theinstrument 100 includes the motor 164. The motor 164 may be anyelectrical motor configured to actuate one or more drives (e.g.,rotatable drive connectors 118, 120, 122 of FIG. 6). The motor 164 iscoupled to the battery 156, which may be a DC battery (e.g.,rechargeable lead-based, nickel-based, lithium-ion based, battery etc.),an AC/DC transformer, or any other power source suitable for providingelectrical energy to the motor 164.

The battery 156 and the motor 164 are coupled to a motor driver circuit404 disposed on the circuit board 154 which controls the operation ofthe motor 164 including the flow of electrical energy from the battery156 to the motor 164. The driver circuit 404 includes a plurality ofsensors 408 a, 408 b, . . . 408 n configured to measure operationalstates of the motor 164 and the battery 156. The sensors 408 a-n mayinclude voltage sensors, current sensors, temperature sensors, pressuresensors, telemetry sensors, optical sensors, and combinations thereof.The sensors 408 a-408 n may measure voltage, current, and otherelectrical properties of the electrical energy supplied by the battery156. The sensors 408 a-408 n may also measure rotational speed asrevolutions per minute (RPM), torque, temperature, current draw, andother operational properties of the motor 164. RPM may be determined bymeasuring the rotation of the motor 164. Position of various driveshafts (e.g., rotatable drive connectors 118, 120, 122 of FIG. 6) may bedetermined by using various linear sensors disposed in or in proximityto the shafts or extrapolated from the RPM measurements. In embodiments,torque may be calculated based on the regulated current draw of themotor 164 at a constant RPM. In further embodiments, the driver circuit404 and/or the controller 406 may measure time and process theabove-described values as a function thereof, including integrationand/or differentiation, e.g., to determine rate of change of themeasured values and the like.

The driver circuit 404 is also coupled to a controller 406, which may beany suitable logic control circuit adapted to perform the calculationsand/or operate according to a set of instructions described in furtherdetail below. The controller 406 may include a central processing unitoperably connected to a memory which may include transitory type memory(e.g., RAM) and/or non-transitory type memory (e.g., flash media, diskmedia, etc.). The controller 406 includes a plurality of inputs andoutputs for interfacing with the driver circuit 404. In particular, thecontroller 406 receives measured sensor signals from the driver circuit404 regarding operational status of the motor 164 and the battery 156and, in turn, outputs control signals to the driver circuit 404 tocontrol the operation of the motor 164 based on the sensor readings andspecific algorithm instructions, which are discussed in more detailbelow. The controller 406 is also configured to accept a plurality ofuser inputs from a user interface (e.g., switches, buttons, touchscreen, etc. of the control assembly 107 coupled to the controller 406).A removable memory card or chip may be provided, or data can bedownloaded wirelessly.

The present disclosure provides for an apparatus and method forcontrolling the instrument 100 or any other powered surgical instrument,including, but not limited to, linear powered staplers, circular orarcuate powered staplers, graspers, electrosurgical sealing forceps,rotary tissue blending devices, and the like. In particular, torque,RPM, position, and acceleration of drive shafts of the instrument 100can be correlated to motor characteristics (e.g., current draw). Thepresent disclosure also provides a feedback system and method forcontrolling the instrument 100 based on external operating conditionssuch as firing difficulty encountered by the instrument 100 due totissue thickness. In addition, the present disclosure provides formodeling of different usages of the instrument 100 in response to theexternal operating conditions (e.g., specific failures) to deriveinternal system feedback.

The sensor information from the sensors 408 a-n is used by thecontroller 406 to alter operating characteristics of the instrument 100and/or notify users of specific operational conditions. In embodiments,the controller 406 controls (e.g., limits) the current supplied to themotor 164 to control the operation of the instrument 100.

FIG. 12 shows a method according to the present disclosure forcontrolling the instrument 100, and in particular, the motor 164. Themethod may be implemented as software instructions (e.g., algorithm)stored in the controller 406. In step 452, the controller 406 sets thecurrent to be supplied to the motor 164 to a first current limit value“A.” This may be done manually or automatically, e.g., preloaded from alook-up table stored in memory. The controller 406 also stores firstupper and lower RPM limit values “X” and “Y,” respectively, associatedwith the first current limit value “A.” In step 454, the controller 406commences operation of the instrument 100 by signaling the motor 164 torotate the drive screw 74 to clamp tissue and/or drive staplestherethrough. The controller 406 signals the drive circuit 404 to drivethe motor 164 at the upper RPM limit value “X.”

In step 456, the drive circuit 404 continually monitors RPM of the motor164 and provides the measurement signals to the controller 406. Thecontroller 406 compares the measured RPM signals to the lower RPM limitvalue “Y.” If the value is above the lower RPM limit value “Y” then thedrive circuit 404 continues to drive the motor 164 at the upper RPMlimit value “X.” If the value is below the lower RPM limit “Y,” whichdenotes that the motor 164 has encountered resistance during firing,e.g., thicker tissue, an obstruction, etc., then in step 458 thecontroller 406 sets the current supplied to the motor 164 to a secondcurrent limit value “B.”

The controller 406 also stores second upper and lower RPM limit values“Z” and “W,” respectively, for the second current limit value “B.” Thesecond current limit value “B” is higher than the first current limitvalue “A” since higher current increases the torque and RPM of the motor164 to overcome the resistance encountered during stapling. In step 460,the controller 406 drives the motor 164 at the upper RPM limit value“Z.”

In step 462, the drive circuit 404 continually monitors RPM of the motor164 and provides the measurement signals to the controller 406. Thecontroller 406 compares the measured RPM signals to the lower RPM limitvalue “W.” If the value is above the lower RPM limit value “W” then thedrive circuit 404 continues to drive the motor 164 at the upper RPMlimit value “Z.” If the value is below the lower RPM limit value “W,”which denotes that the motor 164 has encountered further resistanceduring firing, then in step 464 the controller 406 terminates currentbeing supplied to the motor 164. The second current limit value “B” actsas a final current value at which the motor 164 may be operated.

In embodiments, multiple current limit values may be set for the motor164 and the drive circuit 404 to allow the controller 406 to switchbetween multiple current limit values based on the encounteredresistances. Each of the current limit values may also be associatedwith corresponding upper and lower RPM limit values at which thecontroller 406 switches to a neighboring current limit value. In furtherembodiments, the method may switch back to a lower current limit valueif the encountered resistance has lowered, which may be detected basedon a lower current draw and/or higher RPM limit values.

FIGS. 13-15 illustrate performance plots of the motor 164 during variousoperational situations. FIGS. 13-15 show plots of rotational speed,torque, and current as a function of time. In FIGS. 13-15, horizontalaxis 501 represents reference time expressed as a unitless scale, leftvertical axis 503 represents mechanical resistance on the motor 164(e.g., torque) and RPM of the motor 164, which are not proportional, andright vertical axis 505 represents the current supplied to the motor164. The left vertical axis 503 includes first upper and lower RPM limitvalues “X” and “Y,” respectively, and second upper and lower RPM limitvalues “Z” and “W.” The right vertical axis 505 includes first andsecond current limit values “A” and “B.”

FIGS. 13-15 illustrate various embodiments of the method of FIG. 12.FIG. 13 shows an RPM plot 500, a torque plot 502, and a current plot504. As the firing process commences, the mechanical load on the motor164 remains low and the RPM of the motor 164 are held constant at thefirst upper RPM limit value “X” as shown by the plot 500. The methoddoes not progress beyond the step 456 since the RPMs did not drop belowthe lower RPM limit value “Y.” Consequently, the first current limitvalue “A” is not reached during the firing process as represented by theplot 504 and the torque is also held constant as shown by the plot 502.

FIG. 14 shows an RPM plot 600, a torque plot 602, and a current plot604. As the firing process commences, the mechanical load is initiallyconstant as illustrated in FIG. 13 but increased strain on the motor 164is illustrated at a point 606 of FIG. 14. As the load is increasing, themotor 164 requires more current to maintain the RPM at the upper RPMlimit value “X.” The controller 406 signals the drive circuit 404 tolimit the current below the current limit value “A.”

Increase in the mechanical load results in the RPMs of the motor 164dropping below the lower RPM limit value “Y” and the current exceedingthe first current limit value “A” at a point 608 as represented by theplot 600. With reference to the flow chart of FIG. 12, at step 456 ofthe method, the drop in RPMs of the motor 164 is detected and the highercurrent limit value “B” along with upper and lower RPM limit values “Z”and “W” are set in steps 458 and 460, as described above. At a point610, once the higher current limit value “B” is set, the motor 164continues its operation at the upper RPM limit value “Z” until thefiring process is complete.

FIG. 15 illustrates an RPM plot 700, a torque plot 702, and a currentplot 704. As the firing process commences, the mechanical load isinitially constant as illustrated in FIGS. 13 and 14 but increasedstrain on the motor 164 is illustrated at a point 706. As the load isincreasing, the motor 164 requires more current to maintain the RPM atthe upper RPM limit value “X.” The controller 406 signals the drivecircuit 404 to limit the current below the current limit value “A.”

Increase in the mechanical load results in the RPMs of the motor 164dropping below the lower RPM limit value “Y” at a point 708 asrepresented by the plot 700. With reference to the flow chart of FIG.12, at step 456 of the method, the drop in RPMs of the motor 164 isdetected and the higher current limit value “B” along with upper andlower RPM limit values “Z” and “W” are set in steps 458 and 460, asdescribed above.

At a point 710, once the higher current limit value “B” is set, themotor 164 continues its operation at the upper RPM limit value “Z” inresponse to the higher mechanical load until a point 712, at which themotor 164 encounters additional resistance or strain. As the load isincreasing, the motor 164 requires more current to maintain the RPM atthe upper RPM limit value “Z.” The controller 406 signals the drivecircuit 404 to limit the current below the current limit value “B.”

Further increase in the mechanical load results in the RPMs of the motor164 dropping below the lower RPM limit value “W” and the currentexceeding the second current limit value “B” at a point 712 asrepresented by the plot 700. With reference to the flow chart of FIG.12, at step 462 of the method, the second drop in RPMs of the motor 164is detected and the controller 406 signals the driver circuit 404 toshut off the motor 164 at a point 714, as seen in FIG. 15.

The present disclosure provides several advantages to deviceperformance, safety, and to the end users experience. The instrument 100provides an intuitive feedback method to users during operationincluding visual and audible feedback. In particular, the presentdisclosure lowers the RPM of the motor 164 or shuts the motor 164 as theinstrument 100 encounters increased mechanical load. This basicperformance feedback fulfills a larger user need which was unaddressedby conventional powered devices. Its implementation allows users to moreeffectively use powered instruments.

In any of the embodiments disclosed herein, the reload 300 and adapter200 can be used with an instrument 100 that is powered by air pressure,alternating current (such as a wall socket), a generator, or othermeans. In any of the embodiments, the instrument 100 and adapter 200 canutilize two drive shafts rather than three, or more than three shafts.

In any of the embodiments disclosed herein, the controller can storeinformation about the current, RPM, forces, time, pressure, or otherdata concerning the use of the system. In any of the embodiments,sensors can be provided in the reload 300, or other places in thesystem. In any of the embodiments disclosed herein, the memory canwirelessly transfer the data, upon command or automatically, to anotherstorage device, or a removable chip or card can be provided to storesuch data.

Use of this algorithm to selectively and intelligently alter operationalspeeds can offer further benefits. In embodiments, the instrument 100may decrease firing speed under excessive conditions. This slowingcauses firings to take longer to complete. As a result additional timeis provided in which tissues can compress and fluids can disperse. Thisallows reloads to be fired successfully onto a larger tissue masses thanwould be possible with a static firing speed stapler. Specific changesto RPM and current limit values in specific situations can reduce devicefatigue, improve staple formation, lower internal temperatures,eliminate the need for duty cycles, increase devices functionallifetime, and reliability.

During the use of any surgical instruments one or more safetymechanisms, such as the lockout mechanism 373, may fail. The controller404 determines firing progress of the end effector 300 based on distancetraveled by rotatable drive connectors 118, 120, 122 of FIG. 6.Completion and/or failure of the firing status is stored in the memoryand may be annunciated to the user using various status indicators(e.g., LEDs). Although specific failure of the lockout mechanism 373 isdescribed herein, it is envisioned that correlation of the metrics ofthe motor 164 may be used to provide an additional safety check of themechanical safety lockouts.

FIG. 16 illustrates a performance plot of the motor 164 duringmechanical failure of the lockout mechanism of the 373. In FIG. 16,horizontal axis 801 represents reference time expressed in seconds, leftvertical axis 803 represents current draw of the motor 164. FIG. 16 alsoshows a current draw plot 800 and a processed current draw plot 802. Asthe firing process commences, the mechanical load on the motor 164slightly increases as the drive beam 364 is advanced as shown by theplot 800 until a point 804. The current draw then drops offprecipitously until a point 806, which is indicative of the failure ofthe lockout mechanism 373 (e.g., the locking member 371 fails to engagethe protrusion 303 c). Supply of current is completely shut off at apoint 808 as illustrated by an almost instantaneous drop of current to 0amperes (A).

The plot 802 shows a processed plot that is indicative of the currentdraw. In particular, the current draw of the plot 800 may be processedby the driver circuit 404 and/or the controller 406 to output the plot802. Plot 802 may be generated as a function of the current draw by themotor 164 (e.g., plot 800) and one or more additional metrics of themotor 164 including, but not limited to, time, rotational speed, torque,temperature, position of various drive shafts, and combinations thereof.

The plot 802 tracks the initial current draw until the point 804. Thefirst drop between points 804 and 806 is also reflected in the processedplot 802, which is indicative of the failure of the lockout mechanism373. The current draw then drops off precipitously until the point 808.Supply of current is also completely shut off at the point 808 asillustrated by an almost instantaneous drop in the plot 802 at a point810.

The driver circuit 404 and/or the controller 406 may detect the drop offof the current draw by monitoring the rate of change of the currentdraw. In response to the detection of the failure of the lockoutmechanism 373, the driver circuit 404 and/or the controller 406 stopapplication of current to the motor 164, thereby terminating the firingprocess. In addition, the driver circuit 404 and/or the controller 406may lockout operation of the instrument 100 until end effector 300 isremoved. During lockout, the instrument 100 may become completely orpartially unresponsive to user inputs (e.g., actuation of the controlassembly 107) and may annunciate the fault condition to the user viavarious status indicators (e.g., LEDs). In embodiments, the drivercircuit 404 and/or the controller 406 may store in memory a faultindicator. The fault indicator may be resident in memory until the faultis cleared (e.g., by replacing the end effector 300), thus preventingreuse of the end effector 300.

The disclosed combination of the lockout mechanism 373 and the drivercircuit 404 and/or the controller 406, which detect failure of thelockout mechanism 373 allows for prevention of reuse of the end effector300. Failure of the lockout mechanism 373 (e.g., due to intentionaltampering) may allow for unauthorized reloading of the previously usedend effector 300. The current drop off monitoring by the driver circuit404 and/or the controller 406 allows for prevention of reuse of thepreviously used end effector 300 even when the lockout mechanism 373 isabsent or otherwise malfunctions. The driver circuit 404 and/or thecontroller 406 are configured to only trigger a fault condition when theoperation of the motor 164 is indicative of a failed lockout mechanism373. In other words, the current draw of the motor 164 does not drop offat the point 804 if the lockout mechanism 373 functions properly, thusnot triggering the electronic lockout described above. In any of theembodiments disclosed herein, the surgical system can include more thanone lockout in various locations, and the one or more lockouts can takevarious forms.

In addition to basic feedback about device performance this disclosurealso provides a method for powered devices to detect and discern otherexternal factors, e.g., thicker tissue, which previously were difficultto detect. As a result, improved cutoffs and values for limits can beimplemented, greatly improving the safety of powered devices in use.Using the feedback mechanisms discussed above, users may makeintelligent decisions about what settings and techniques should be usedwhen operating the instrument 100. This intelligence can range fromchoosing a different reload to fire with a linear stapler, deciding tofire at a different articulation angle, to choosing to use a completelydifferent surgical technique.

It should be understood that the foregoing description is onlyillustrative of the present disclosure. Various alternatives andmodifications can be devised by those skilled in the art withoutdeparting from the disclosure. Accordingly, the present disclosure isintended to embrace all such alternatives, modifications and variances.The embodiments described with reference to the attached drawing figuresare presented only to demonstrate certain examples of the disclosure.Other elements, steps, methods and techniques that are insubstantiallydifferent from those described above and/or in the appended claims arealso intended to be within the scope of the disclosure.

What is claimed is:
 1. A surgical instrument, comprising: a handleassembly; a jaw assembly comprising a staple cartridge containing aplurality of staples and an anvil to form the plurality of staples uponfiring; a lockout mechanism configured to prevent reuse of the jawassembly; a drive assembly at least partially located within the handleand connected to the jaw assembly and the lockout mechanism; a motoroperatively coupled to the drive assembly; and a controller operativelycoupled to the motor, the controller configured to control supply ofelectrical current to the motor and to monitor a current draw of themotor, wherein the controller is further configured to terminate thesupply of electrical current to the motor in response to a drop in thecurrent draw indicative of a failure of the lockout mechanism.
 2. Thesurgical instrument according to claim 1, wherein the jaw assemblycomprises a drive beam coupled to the lockout mechanism, the lockoutmechanism configured to transition between an unlocked state and alocked state upon distal movement of the drive beam.
 3. The surgicalinstrument according to claim 2, wherein the drop in the current drawcorresponds to a failure of the lockout mechanism to transition into thelocked state upon retraction of the drive beam.
 4. The surgicalinstrument according to claim 3, wherein the lockout mechanism comprisesa locking member pivotal between an unlocked position and a lockedposition.
 5. The surgical instrument according to claim 4, wherein thejaw assembly further comprises a housing defining a projection mountedtherein configured to engage the locking member upon retraction of thedrive beam.
 6. A surgical instrument, comprising: a handle assembly; adisposable end effector removably coupled to the handle assembly, thedisposable end effector comprising a jaw assembly including a staplecartridge containing a plurality of staples and an anvil to form theplurality of staples upon firing; a drive assembly at least partiallylocated within the handle and connected to the jaw assembly, the driveassembly comprising a lockout mechanism; a motor operatively coupled tothe drive assembly; a drive circuit coupled to the motor and configuredto measure a current draw of the motor; and a controller operativelycoupled to the motor, the controller configured to terminate the supplyof electrical current to the motor in response to a drop in the currentdraw indicative of a failure of the lockout mechanism.
 7. The surgicalinstrument according to claim 6, wherein the controller is furtherconfigured to store a fault state in a memory in response to the drop inthe current draw.
 8. The surgical instrument according to claim 7,wherein the fault state is cleared after the disposable end effector isremoved from the handle assembly.
 9. The surgical instrument accordingto claim 6, wherein the controller is configured to detect the drop inthe current draw based on a rate of change of the current draw.
 10. Thesurgical instrument according to claim 6, wherein the jaw assemblycomprises a drive beam coupled to the lockout mechanism.
 11. Thesurgical instrument according to claim 10, the lockout mechanismconfigured to transition between an unlocked state and a locked stateupon distal movement of the drive beam.
 12. The surgical instrumentaccording to claim 11, wherein the drop in the current draw correspondsto a failure of the lockout mechanism to transition into the lockedstate upon retraction of the drive beam.
 13. The surgical instrumentaccording to claim 12, wherein the lockout mechanism comprises a lockingmember pivotal between an unlocked position and a locked position. 14.The surgical instrument according to claim 13, wherein the jaw assemblyfurther comprises a housing defining a projection mounted thereinconfigured to engage the locking member upon retraction of the drivebeam.
 15. The surgical instrument according to claim 6, furthercomprising a control assembly coupled to the controller, wherein thecontroller disregards user inputs in response to the drop in the currentdraw.
 16. A method for controlling a surgical instrument, the methodcomprising: activating a motor operatively coupled to a disposable endeffector, the disposable end effector comprising: a drive beam coupledto a jaw assembly comprising a staple cartridge containing a pluralityof staples and an anvil to form the plurality of staples upon firing;and a lockout mechanism coupled to the drive beam and configured totransition from an unlocked state to a locked state upon retraction ofthe drive beam; measuring a current draw of the motor; and terminatingsupply of electric current to the motor in response to a drop off of thecurrent draw indicative of a failure of the lockout mechanism.
 17. Themethod according to claim 16, further comprising: storing a fault statein a memory in response to the drop in the current draw.
 18. The methodaccording to claim 17, further comprising: clearing the fault stateafter the disposable end effector is removed from the handle assembly.